10 Anti-infective PD - A Widening GapDemand = PullRespond to the needs of the marketplace. Need to be flexible, contractual, committable, not to be subject to political change.Supply = PushResearch provides new opportunities that lead to innovation.due to market forces beyond biodefenseNIHProvider of acquisition $$

12 Reality Check Myth: Reality:Scientific breakthroughs lead to new productsReality:Scientific breakthroughs lead to new concepts that may yield a new product after decades of trial and error (mostly error) and at least 3 orders of magnitude more funding

13 Reality Check Myth: Reality:Phase III clinical trials are responsible for most of the costs of clinical development for new medical productsReality:Total clinical trial costs (including costs of goods) typically amount to only 20 – 25% of the total clinical development costs

14 Reality Check Myth: Reality:The ‘Animal Rule’ will drastically reduce development time and costs for biodefense products compared to traditional pharmaceutical developmentReality:‘Animal Rule’ models are disease models (rather than infection models), accepted by the FDA, and performed under GLP conditions with cGMP product including detailed PK/PD or correlates of protection analysis combined with human PK or immunogenecity data